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ThermoGenesis Develops Blood Test to Detect COVID-19 in Minutes

ThermoGenesis Holdings, Inc. (Rancho Cordova, CA, USA), which provides automated cell processing tools and services in the cell and gene therapy field, has developed an advanced point-of-care test that will allow rapid diagnosis of the COVID-19 virus, including asymptomatic cases, using just a single drop of blood without the need for special lab equipment and deliver results in less than 10 minutes.

ThermoGenesis develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. The company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally-closed CAR-TXpress platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market.

ThermoGenesis’ SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit is designed to allow pre-screening for COVID-19 infections as well as identification of individuals who have encountered the virus and have developed protective immunity. Requiring just a single drop of blood, the Kit is intended for professional use and will deliver results — with no lab equipment necessary — in less than 10 minutes, at the point-of-care. The company is currently completing validations in accordance with the “Policy for Diagnostic Test for Coronavirus Disease – 2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturer, and Food and Drug Administration Staff issued on March 16, 2020 for Serological Diagnostics.” ThermoGenesis will notify the FDA upon completion of validation prior to product launch.

“The company has been in discussions with healthcare distributors, healthcare institutions, medical practitioners and government agencies, and is working quickly to bring the COVID-19 Test Kits to the US professional medical community,” said Chris Xu, Ph.D, Chief Executive Officer of ThermoGenesis. “This Kit will not only allow pre-screening for COVID-19 infections, but will also allow identification of individuals who have encountered the virus and have developed protective immunity. This will be essential in expediting the safety required to get the nation back to work in the future.”